D-0126440-A – 2020/08
VisualEyes™ 515/525 Instructions for Use - US Page 39
6.5 Electromagnetic compatibility (EMC)
This section is valid for the VisualEyes™ system including all variant of goggles.
This equipment is suitable in hospital and clinical environments except for near-active HF surgical equipment
and RF-shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic
disturbance is high.
Use of this equipment adjacent to other equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other equipment should be observed to verify that
they are operating normally.
Use of accessories and cables other than those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation. The list of accessories and cables can be found in this section.
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of this equipment, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could occur.
NOTICE ESSENTIAL PERFORMANCE for this equipment is defined by the manufacturer as:
This equipment does not have an ESSENTIAL PERFORMANCE Absence or loss of ESSENTIAL
PERFORMANCE cannot lead to any unacceptable immediate risk.
Final diagnosis shall always be based on clinical knowledge.
This equipment complies with IEC60601-1-2:2014, emission class B group 1.
NOTICE: There are no deviations from the collateral standard and allowances uses.
NOTICE: All necessary instructions for maintenance comply with EMC and can be found in the general
maintenance section in this instruction. No further steps required.
Portable and mobile RF communications equipment can affect the ORION. Install and operate the ORION
according to the EMC information presented in this chapter.
The ORION has been tested for EMC emissions and immunity as a standalone ORION. Do not use the
ORION adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the
user should verify normal operation in the configuration.
The use of accessories, transducers and cables other than those specified, except for servicing parts sold by
Interacoustics A/S as replacement parts for internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the device.
Anyone connecting additional equipment is responsible for making sure the system complies with the IEC
60601-1-2 standard.
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